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Association between emotional distress and response to Neoadjuvant Chemoimmunotherapy in resectable non-small-cell lung cancer: a prospective observational protocol (NeoFUSE-Lung Trail)

Association between emotional distress and response to Neoadjuvant Chemoimmunotherapy in resectable non-small-cell lung cancer: a prospective observational protocol (NeoFUSE-Lung Trail)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119872
Enrollment
Unknown
Registered
2026-03-04
Start date
2026-03-04
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable non-small-cell lung cancer

Interventions

The observation group of resectable non-small cell lung cancer:None

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. According to the 8th edition AJCC staging criteria, it is stage II-IIIB and determined by thoracic surgery specialists (after multi-disciplinary team consultation as per institutional practice) that the lesion is resectable. 2. Age >= 18 years old. 3. ECOG performance status score of 0-1. 4. Baseline imaging examination shows at least one measurable lesion according to RECIST v1.1 criteria. 5. Plan to use PD-1/PD-L1 inhibitor combined with chemotherapy as the first-line neoadjuvant treatment. 6. Organ and bone marrow functions meet the institutional standards and are safe for treatment. 7. Sign the informed consent form before the trial. 8. Histological or cytological confirmed, untreated NSCLC.

Exclusion criteria

Exclusion criteria: 1. There are targetable genetic mutations such as EGFR exon 19 deletion or exon 21 L858R mutation, ALK fusion or ROS1 fusion. 2. Currently suffering from other types of malignant tumors or having a history of malignant tumors within the past 10 years. 3. Currently participating in other clinical trials that may interfere with the assessment results of this study. 4. Currently suffering from acute or chronic mental disorders or having cognitive dysfunction. 5. Currently receiving antidepressant/anxiety medication treatment or having received psychological treatment within the past 6 months. 6. Used systemic corticosteroids continuously within 1 month before the baseline assessment (except for physiological replacement doses). 7. Have active infections, active or refractory autoimmune diseases, uncontrolled systemic diseases, etc. that may affect the assessment results or increase risks. 8. Unable to cooperate or complete the scale assessment.

Design outcomes

Primary

MeasureTime frame
Hospital Anxiety and Depression Scale score;

Countries

China

Contacts

Public ContactZhang Yang;Yuanpu Wei

Fujian Medical University Union Hospital

zhangyang@fjmu.edu.cn+86 591 8621 8408

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026